Compile, write, edit, and coordinate medical writing deliverables presenting scientific information clearly and accurately

Complete clinical study protocols and protocol amendments, clinical study reports, patient narratives, and investigator brochures

Apply regulatory standards, ICH E3 guidelines, SOPs, client standards, approved templates, authorship requirements, and style guides

Coordinate quality and editorial reviews, lead document reviews, and resolve client comments

Manage source documentation appropriately

Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency

Build working relationships with clients, department heads, and peers

Perform online clinical literature searches while complying with copyright requirements

Identify and propose solutions to document issues, escalating when appropriate

Continue professional development and improve awareness of industry standards and best practices

Work within assigned project budgets and communicate status or changes to medical writing leadership

Complete required administrative tasks and other assigned duties

Requirements

Work as a medical writer with moderate supervision

Ability to compile, write, edit, and coordinate medical writing deliverables

Ability to complete clinical study protocols and protocol amendments, clinical study reports, patient narratives, and investigator brochures

Knowledge of ICH E3 guidelines and regulatory standards

Ability to follow company and client standard operating procedures, templates, authorship requirements,



and style and formatting guides

Ability to coordinate quality and editorial reviews and manage source documentation

Ability to review statistical analysis plans and table/figure/listing specifications

Ability to perform online clinical literature searches and comply with copyright requirements

Ability to identify and propose solutions to document issues

Ability to work within budgeted hours and communicate status and changes to medical writing leadership

Minimal travel may be required (less than 25%)

Equivalent experience, skills, and/or education may be considered

Core Competencies Demonstrates expertise in medical writing, including the ability to compile, write, edit, and coordinate clinical study documents while adhering to regulatory standards and ICH E3 guidelines. Proficient in managing quality reviews and maintaining effective communication with clients and stakeholders.

Highest-signal resume keywords

Medical Writing

Clinical Study Protocols

ICH E3 Guidelines

Quality Review Coordination

Statistical Analysis Review

Hard Skills

Medical Writing Deliverables

Clinical Study Reports

Protocol Amendments

Patient Narratives

Investigator Brochures

Regulatory Standards

SOPs

Document Issue Resolution

Online Clinical Literature Searches

Budget Management

Soft Skills

Communication

Collaboration

Problem Solving

Relationship Building

Attention to Detail

Industry Keywords

Regulatory Standards

ICH E3 Guidelines

Copyright Compliance

Editorial Reviews

Document Management

#J-18808-Ljbffr

📌 Medical Writer – Future roles (Madrid)
🏢 Jobtailor
📍 Madrid